Preliminary Advice for Patients*: Possible Contamination and Malfunction of Heart Valves and Valve Conduits, Annuloplasty Rings, Surgical Grafts, Meshes and Other Medical Devices Manufactured by Shelhigh, Inc. (archived)
This is an archived document. FDA has updated this document, based on information obtained during seizure. See the updated document.
Issued: April 18, 2007
FDA has seized all implantable medical devices manufactured by Shelhigh, Inc., Union, NJ, because they were manufactured under conditions that may have contaminated the devices. Therefore, these devices may fail to properly function. FDA is providing the following information for patients and their families, so they will be better able to discuss the best course of action with their doctors. We will update this advice if necessary as more information becomes available.
Patients should understand that an FDA seizure means that the existing devices at the company will not be introduced into the market, but it does not necessarily mean that the device needs to be removed from the patient. Seizure is meant to stop further distribution of a product.
Shelhigh, Inc. devices may have been implanted during various surgical procedures, including open-heart surgery for valve replacement; and repair of soft tissue structures during abdominal, pelvic, heart, lung, brain, shoulder, and spine surgery. Patients who are vulnerable to infection and are at greatest risk for unexpected complications from the use of these devices include: the critically ill, children, the elderly, and pregnant women.
The number of these devices that may be contaminated or experience problems isn’t known at this time. These devices have been available since 1997. Problems with the device could occur at anytime, and may become apparent to you and your physician during routine examination. Physicians have been notified of the problems associated with these medical devices.
Advice for Patients
- If you don’t know if you have one of the devices in question, contact the doctor who performed your surgery.
- If you know you have one of the devices in question, you should:
- Contact your doctor promptly
- Follow your doctor’s instructions on care after surgery
- Do not miss any follow-up appointments with your physician
- Contact your physician if you have ANY signs of infection, such as
- Unusual pain, swelling, redness, and warmth in the area of your implant
- Drainage or discharge from the incision used during the procedure to implant the device
- Inform all your doctors about your surgery and that you may have a Shelhigh device implanted.
You may also contact FDA’s Division of Small Manufacturers, International and Consumer Assistance at 1-800-638-2041. For consumer information, select #2, or to speak with a Medical Device Specialist, select #4.
* CDRH Preliminary Advice for Patients is intended to quickly share device-related safety information with the public when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.